Loading clinical trials...

A Drug-drug Interaction Study of Avapritinib and Midazolam | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Drug-drug Interaction Study of Avapritinib and Midazolam

A Drug-drug Interaction Study to Investigate the Effect of Avapritinib on the Pharmacokinetics of Midazolam in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) and Other Advanced Solid Tumors

NCT04908176•Blueprint Medicines Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effect of multiple dosing of avapritinib on the pharmacokinetics (PK) of midazolam in adult patients with metastatic or unresectable gastrointestinal stromal tumors (GIST), recurrent gliomas, or other KIT mutant tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Must be ≥18 years of age at the time of signing the informed consent
•2. Confirmed diagnosis of
•* metastatic or unresectable KIT mutant GIST that has recurred or progressed after at least 4 lines of prior systemic SOC therapy or the Investigator has determined that treatment with SOC therapy is not appropriate for patients who failed at least 2 lines of prior SOC
•OR
•---Non-resectable advance solid tumor with KIT mutation with progression following standard of care treatment.
•OR
•---Confirmed diagnosis of recurrent or unresectable CNS tumors including :IDH-mutant astrocytoma, IDH-mutant oligodendroglioma, glioblastoma, H3K27-altered diffuse midline glioma, H3G34-mutant diffuse hemispheric glioma, midline glioma (with unknown H3K27 mutation status) that has failed prior radiation or systemic SOC therapy.
•3. Must be able to swallow an oral medication
•4. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
•5. Patient agrees to use contraception consistent with local regulations
+10 more criteria

Exclusion Criteria

•1. Patients with GIST that harbors a known PDGFRA mutation
•2. Known hypersensitivity to avapritinib, midazolam, or any of their excipients
•3. Have received previous therapy with avapritinib
•4. Have any of the following laboratory abnormalities before the first dose of study drug:
•* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>3 × upper limit of normal (ULN) if no hepatic metastases are present; \>5 × ULN if hepatic metastases are present
•* Total bilirubin \>1.5 × ULN; \>3 × ULN in the presence of Gilbert's Disease
•* Estimated (Cockcroft-Gault formula) or measured creatinine clearance \<60 mL/min
•* Platelet count \<100 × 10\^9/liter (L)
•* Absolute neutrophil count (ANC) \<1.0 × 10\^9/L
•* Hemoglobin \<9 grams per deciliter (g/dL). Transfusion and erythropoietin may be used to reach at least 9 g/dL but must have been administered at least 2 weeks before the first dose of the study drug.
+8 more criteria

Locations (3)

Mayo Clinic Florida

Jacksonville, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

August 24, 2022

Primary Completion Date

March 1, 2024

Completion Date

May 10, 2024

Last Updated

December 13, 2024

Enrollment

ACTUAL participants

Conditions

Gastrointestinal Stromal TumorsGISTNon-resectable Advanced Solid TumorsRecurrent or Unresectable Central Nervous System (CNS) Tumors

Interventions

Avapritinib

DRUG

midazolam

DRUG

Familial Investigations of Childhood Cancer Predisposition

NCT03050268

Acute LeukemiaAdenomatous Polyposis+44 more

View study

RECRUITINGPHASE1

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

NCT06655246

Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal Cancer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Drug-drug Interaction Study of Avapritinib and Midazolam

Inclusion Criteria

Exclusion Criteria

Familial Investigations of Childhood Cancer Predisposition

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors

Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study